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ERIVEDGE Drug Profile

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When do Erivedge patents expire, and what generic alternatives are available?

Erivedge is a drug marketed by Genentech and is included in one NDA. There are two patents protecting this drug.

This drug has forty-three patent family members in twenty-two countries.

The generic ingredient in ERIVEDGE is vismodegib. One supplier is listed for this compound. Additional details are available on the vismodegib profile page.

Summary for ERIVEDGE

International Patents:	43
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	89
Clinical Trials:	37
Patent Applications:	49
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ERIVEDGE
DailyMed Link:	ERIVEDGE at DailyMed

Generic Entry Opportunity Date for ERIVEDGE

NDA:

203388

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for ERIVEDGE

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

Synonyms for ERIVEDGE

085G559

2-Chloranyl-~{n}-(4-Chloranyl-3-Pyridin-2-Yl-Phenyl)-4-Methylsulfonyl-Benzamide

2-chloro-n-(4-chloro-3-(2-pyridinyl)phenyl)-4-(methylsulfonyl)benzamide

2-Chloro-N-(4-chloro-3-(2-pyridl)phenyl)-4-(methylsulfonyl)benzamide

2-chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methyl sulfonyl)benzamide

2-chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide

2-chloro-N-(4-chloro-3-pyridin-2-yl-phenyl)-4-methanesulfonyl-benzamide

2-chloro-N-(4-chloro-3-pyridin-2-ylphenyl)-4-methylsulfonylbenzamide

2-CHLORO-N-[4-CHLORO-3-(2-PYRIDINYL)PHENYL]-4-(METHYLSULFONYL)-BENZAMIDE

2-Chloro-N-[4-chloro-3-(2-pyridinyl)phenyl]-4-(methylsulfonyl)benzamide

2-chloro-N-[4-chloro-3-(2-pyridyl)phenyl]-4-methylsulfonyl-benzamide

2-chloro-N-[4-chloro-3-(pyridin-2-yl)phenyl]-4-(methylsulfonyl)benzamide

2-chloro-N~1~-[4-chloro-3-(2-pyridyl)phenyl]-4-(methylsulfonyl)benzamide

25X868M3DS

4CA-1325

879085-55-9

A10467

AB0008125

AB01565813_02

ABP000894

AC-26969

AJ-103831

AK-77261

AKOS015966534

AN-471

ANW-60962

AOB1040

AS-14066

AX8167197

BC660083

BCP9000713

BCPP000223

BDBM50249522

Benzamide, 2-chloro-N-(4-chloro-3-(2-pyridinyl)phenyl)-4-(methylsulfonyl)-

BENZAMIDE, 2-CHLORO-N-[4-CHLORO-3-(2-PYRIDINYL)PHENYL]-4-(METHYLSULFONYL)-

BG0661

BPQMGSKTAYIVFO-UHFFFAOYSA-N

C19H14Cl2N2O3S

C538724000

CHEBI:66903

CHEMBL473417

CS-0255

CTK8B8648

CUR-691

D03EDQ

D09992

D0LB7J

DB08828

DTXSID40236689

Erivedge (TN)

FT-0675833

GD 0449|||2-Chloro-N-[4-chloro-3-(2-pyridinyl)phenyl]-4-(methylsulfonyl)benzamide

GDC 0449

GDC-0449

GDC-0449 - Selumetinib

GDC-0449 (Vismodegib)

GDC-0449, GDC0449, GDC 0449, 879085-55-9

GDC-0449,Vismodegib

GDC-0449,Vismodegib, HhAntag691

GDC-0449(Vismodegib)

GDC-0449(Vismodegib)/GDC0449

GDC-449

GDC0449

GTPL6975

HE067811

HE401106

Hh-Antag691

HhAntag691

HMS3604K16

HMS3654E17

HSDB 8130

HY-10440

J-509076

J90022

KB-308771

KB-81450

KS-000000BH

MCULE-6680076172

MFCD12407408

MLS006012035

MolPort-009-679-417

NCGC00242497-01

NCGC00242497-02

NSC 747691

NSC-747691

NSC-755986

NSC747691

NSC755986

PB15086

PubChem19137

Q-2305

QCR-40

R 3616

R-3616

RG-3616

RG3616

RL05479

s1082

SC-87729

SCHEMBL302587

SMR004703564

SR-01000941574

SR-01000941574-1

ST24040458

TC-149707

UNII-25X868M3DS

V-4050

VIS

Vismodegib

Vismodegib (GDC-0449)

Vismodegib (SHH inhibitor)

Vismodegib (USAN/INN)

Vismodegib [USAN:INN]

Vismodegib, free base

vismodegibum

X4669

ZINC40899447

US Patents and Regulatory Information for ERIVEDGE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes			Y	Y

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Non-Orange Book US Patents for ERIVEDGE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,321,761	Pyridyl inhibitors of hedgehog signalling
9,790,183	Pyridyl inhibitors of hedgehog signalling

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International Patents for ERIVEDGE

Country	Document Number	Estimated Expiration
Denmark	1789390
Norway	339260
World Intellectual Property Organization (WIPO)	2006028958
South Korea	20130083488
Eurasian Patent Organization	201100604
Mexico	2007002584
Brazil	PI0514841

Supplementary Protection Certificates for ERIVEDGE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2013000074	Germany		PRODUCT NAME: ERIVEDGE - VISMODEGIB; NAT. REGISTRATION NO/DATE: EU/1/13/848 20130712; FIRST REGISTRATION: SCHWEIZ IKS-NR. 62497 20130530
0 12-2013	Slovakia		PRODUCT NAME: VISMODEGIB; REGISTRATION NO/DATE: EU/1/13/848/001 20130712
2013024	Lithuania		PRODUCT NAME: VISMODEGIBUM; NAT. REGISTRATION NO/DATE: SWISS 62497 01 20130530; FIRST REGISTRATION: EU/1/13/848 20130712
2013 00050	Denmark		PRODUCT NAME: VISMODEGIB; NAT. REG. NO/DATE: EU71/13/848 20130712; FIRST REG. NO/DATE: CH 62497 20130530
2013024,C1789390	Lithuania		PRODUCT NAME: VISMODEGIBUM; NAT. REGISTRATION NO/DATE: SWISS 62497 01 20130530; FIRST REGISTRATION: EU/1/13/848 20130712
1789390/01	Switzerland		PRODUCT NAME: VISMODEGIB; REGISTRATION NO/DATE: SWISSMEDIC 62497 30.05.2013
90057-6	Sweden		PRODUCT NAME: VISMODEGIB OCH SOLVAT DAERAV; NAT. REG. NO/DATE: EU/1/13/848 20130712; FIRST REG.: CH IKS-NR 62497 20130530